CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D006331: Heart Diseases NIH

(Synonyms: Heart Di, Heart Dis, Heart Dise, Heart Diseas, Heart Disease, Heart Diseases)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug763 Dietary Intervention Wiki 0.50
drug285 BCG vaccine Wiki 0.29
drug923 Favipiravir Wiki 0.12
drug1270 Ivermectin Wiki 0.12
drug1086 Hydroxychloroquine Wiki 0.05
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (11)


Name (Synonyms) Correlation
D006330 Heart Defects, Congenital NIH 0.35
D003327 Coronary Disease NIH 0.25
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.18
D008173 Lung Diseases, Obstructive NIH 0.17
D008171 Lung Diseases, NIH 0.13
D007249 Inflammation NIH 0.10
D014777 Virus Diseases NIH 0.06
D007239 Infection NIH 0.06
D003141 Communicable Diseases NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0001627 Abnormal heart morphology HPO 0.35
HP:0006510 Chronic pulmonary obstruction HPO 0.18
HP:0006536 Pulmonary obstruction HPO 0.17
HP:0002088 Abnormal lung morphology HPO 0.13

There are 4 clinical trials

Clinical Trials


1 PREDICT 2: Personalized Responses to Dietary Composition Trial 2

Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways. Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease. The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome. The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.

NCT03983733 Diabetes Heart Diseases Diet Habit Diet Modification Microbial Colonization Healthy Obesity Metabolism Other: Dietary Intervention
MeSH:Communicable Diseases Infection Heart Diseases

Primary Outcomes

Description: Species count in fecal sample

Measure: Gut microbiome species richness

Time: 1 Day

Description: Measurement of blood lipids

Measure: Lipids

Time: 3 days

Description: Measurement of blood glucose

Measure: Glucose

Time: 11 days

Description: Record of sleep pattern using a wearable device (i.e. fitness watch)

Measure: Sleep

Time: 10 days

Description: Record of physical activity using a wearable device (i.e. fitness watch)

Measure: Physical activity

Time: 10 days

Description: Record of hunger and appetite patterns using a digital app

Measure: Hunger and appetite assessment

Time: 10 days

Secondary Outcomes

Description: C-peptide

Measure: Glucose metabolism

Time: 3 days

Description: Weighed food log

Measure: Dietary assessment

Time: 10 days

Description: Weight (kg)

Measure: Anthropometry

Time: 1 day

Description: Height (cm)

Measure: Anthropometry

Time: 1 day

Description: Hip and waist circumference (cm)

Measure: Anthropometry

Time: 1 day

Description: Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)

Measure: Metabolomics by NMR analysis

Time: 1 day

Description: Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.

Measure: Dietary assessment

Time: 1 month

Description: Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.

Measure: Covid-19 symptom assessment

Time: 6 months

2 Impact of Covid-19 in Congenital Heart Disease - COVID-CHD

The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer. The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients. CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today. The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population. This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France

NCT04336384 Congenital Heart Disease Covid-19
MeSH:Heart Diseases Heart Defects, Congenital
HPO:Abnormal heart morphology

Primary Outcomes

Description: Prevalence of Covid-19 infection in the overall CHD population

Measure: Prevalence of Covid-19 infection in the overall CHD population

Time: through study completion, an average of 2 weeks

Secondary Outcomes

Description: Prevalence of Covid-19 infection per CHD sub-group

Measure: Prevalence of Covid-19 infection per CHD sub-group

Time: through study completion, an average of 2 weeks

Description: Cardiovascular complications

Measure: Cardiovascular complications

Time: through study completion, an average of 2 weeks

Description: Other complications

Measure: Other complications

Time: through study completion, an average of 2 weeks

Description: Number of deaths

Measure: Number of deaths

Time: through study completion, an average of 2 weeks

3 A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial

Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

NCT04414267 COVID-19 Virus Diseases Corona Virus Infection Coronary Heart Disease Chronic Obstructive Pulmonary Disease Biological: BCG vaccine Biological: Placebo
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Heart Diseases Coronary Disease Virus Diseases
HPO:Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

Time: Visit 3 (90 +/- 5 days)

Secondary Outcomes

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

Time: Visit 4 (135 +/- 5 days)

Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

Time: Visit 5 (180 +/- 5 days)

Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

Measure: Prevalence of IgG/IgM against SARS-CoV-2

Time: Screening Visit and Visit 3 (90 +/- 5 days)

Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

Measure: The impact of new cardiovascular events between the two study groups

Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

4 Long-term Sequelae of Severe Sars-CoV-2 Infections

By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.

NCT04442789 Lung Diseases Cardiac Disease Inflammatory Reaction
MeSH:Lung Diseases Heart Diseases Inflammation
HPO:Abnormal lung morphology

Primary Outcomes

Description: Identify organ dysfunction after SARS-CoV-2 infections

Measure: Sequelae after COVID-19

Time: 12 months, extension if required


HPO Nodes