Clinical trials: Single-ventricle Physiology
Univentricular Heart, Congenital Heart Disease
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Background: The Fontan operation has been used to treat complex cardiac anomalies with a single-functioning ventricle. A study performed by Instituto do Coracão-Hospital das Clínicas-Universidade de Sao Paulo…
- Conditions
- Univentricular Heart, Congenital Heart Disease, Lymphatic Abnormalities, Functional Capacity
- Trial name
- NCT05934578
- Testing
- Exercise training
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- University of Sao Paulo
Ischemic Cardiomyopathy
Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination…
- Trial name
- CONCERT-HF (NCT02501811)
- Testing
- Mesenchymal Stem Cells (MSC), c-kit+ cells
- Where
- 7 sites in United States
- Volunteers
- 125 people
- Sponsor
- The University of Texas Health Science Center, Houston
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Heart Failure, Aortic Stenosis, Severe
Effects of Levosimendan on Cardiac Function After TAVR in Patients With Heart Failure
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve…
- Trial name
- NCT06196177
- Testing
- Levosimontane injection
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Qilu Hospital of Shandong University
Hypoxia, Normobaric Hypoxia
Effect of Acute Hypoxia on RIght VEntRicular Function in Healthy Adults.
More and more people are engaging in sports in the mountains, including individuals with heart or lung diseases. At the same time, such diseases are becoming more common in Switzerland.
- Conditions
- Hypoxia, Normobaric Hypoxia, Altitude Hypoxia, Right Heart Function
- Trial name
- RIVER-H (NCT07431567)
- Testing
- Normobaric Hypoxia
- Where
- 2 sites in Switzerland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mona Lichtblau
Congenital Heart Defect, Hypoplastic Left Heart Syndrome
Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)
Single ventricular (SV) heart was a uniformly fatal condition before the advances in surgical treatment in 1980. In the present era, 5-year survival rate with SV is 75%, with some centers, including the Stollery Children's…
- Conditions
- Congenital Heart Defect, Hypoplastic Left Heart Syndrome, Physical Activity
- Trial name
- MedBike (NCT04056416)
- Testing
- MedBIKE
- Where
- Canada
- Volunteers
- 4 people
- Sponsor
- University of Alberta
Chronic Obstructive Pulmonary Disease, COPD
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD…
- Trial name
- CLAIM (NCT02442206)
- Testing
- QVA149
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle…
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Trial name
- TEMPO (NCT01292551)
- Testing
- Bosentan
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 75 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Left Ventricular Assist Devices Patients
REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study
Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths, 1% of public health expenditure each year in France.
- Trial name
- REVADE (NCT02067455)
- Testing
- adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Rennes University Hospital
Single-ventricle
Inspiratory Muscle Therapy in Subjects With Fontan Circulations
Individuals who have undergone the Fontan procedure are uniquely dependent upon respiratory mechanics to support pulmonary blood flow (PBF).
- Trial name
- NCT03339466
- Testing
- Inspiratory muscle therapy
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Hypoplastic Left Heart Syndrome, Single Ventricle
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure
- Trial name
- TICAP (NCT01273857)
- Testing
- Autologous cardiac progenitor cell transplantation, staged shunt procedure
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Okayama University
Right Ventricular Dysfunction
General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function
The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation of stress response, decrease in pulmonary vascular resistance, myocardial protection and positive myocardial oxygen balance will cause…
- Trial name
- NCT03013075
- Testing
- Spinal anesthesia with Bupivacaine heavy and Morphine, Bupivacaine heavy and Morphine, General Anesthetics
- Where
- India
- Volunteers
- 50 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Fontan Physiology, Frailty
WE BEAT - HEART Club Fontan Wellness Project: A Virtual Resilience Promotion and Frailty Prevention Program
This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of…
- Conditions
- Fontan Physiology, Frailty, Single Ventricle Heart Disease
- Trial name
- NCT05199857
- Testing
- WE BEAT Group Wellness Education program - phase 1, HEART Club Home Exercise program - phase 2
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan
Hypoplastic Left Heart, Congenital Heart Disease
Cardiac Biomarkers in Patients With Single Ventricle Physiology
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and…
- Conditions
- Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Cardiac Disease
- Trial name
- NCT03678909
- Testing
- Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Baylor College of Medicine
Pulmonary Hypertension
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery
The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular…
- Trial name
- NCT02865733
- Testing
- Remodulin, distilled water
- Volunteers
- 36 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Postoperative Complications, Heart Failure
Association Between Portal Flow Pulsatility and Right Ventricular Dysfunction in the Postoperative Period of Cardiac Surgery
Right ventricular dysfunction (RVD) after cardiac surgery is associated with ischemia and myocardial injury. While echocardiographic measures like Tricuspid Annular Plane Systolic Excursion (TAPSE) are frequently used to assess…
- Trial name
- LIFESAVE (NCT06777355)
- Testing
- Transthoracic and Transesophageal echography within 24 hours post cardiac surgery
- Where
- France
- Volunteers
- 32 people
- Sponsor
- CMC Ambroise Paré
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the…
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
- Trial name
- NCT02251431
- Testing
- BYDUREON
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Baylor Research Institute
Left Ventricle Function
Investigate the Effect of AZD1305 on Patients With Left Ventricular Dysfunction
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
- Trial name
- NCT00748982
- Testing
- AZD1305
- Where
- Sweden
- Volunteers
- 16 people
- Sponsor
- AstraZeneca
Myocardial Infarction, Echocardiography 2D
Left Ventricular Function After Primary Percutaneous Coronary Intervention: Role of Speckle Echocardiography
Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily…
- Conditions
- Myocardial Infarction, Echocardiography 2D, Left Ventricular Dysfunction
- Trial name
- NCT04103008
- Testing
- Speckle tracking echocardiography
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Assiut University