Heart Failure, Systolic Clinical Trial
— SODA-HFOfficial title:
Effect of Moderate vs Severe Sodium Restriction on Brain Natriuretic Peptide in Patients With Heart Failure and Reduced Ejection Fraction
Verified date | September 2020 |
Source | Instituto Mexicano del Seguro Social |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The SODA-HF trial is a randomized, double-blind, controlled trial to evaluate the effect of
moderate to severe sodium restriction on brain natriuretic peptide in patients with heart
failure and reduced ejection fraction (less than 40%).
Secondary outcomes are quality of life, NYHA functional class, glomerular filtration rate,
renin plasmatic activity, aldosterone and composite clinical outcome (all-cause mortality and
cardiovascular hospitalization)
Status | Completed |
Enrollment | 70 |
Est. completion date | August 1, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients with a diagnosis of stable heart failure and decreased left ventricular ejection fraction. Such definition will contemplate the following: 1. Patients should have an echocardiogram of maximum 6 months old with a left ventricular ejection fraction of less than 40%. 2. Functional class I, II or III of the NYHA 3. Optimal medical treatment which should include: an angiotensin converting enzyme inhibitor or angiotensin receptor blocker ARA, and a beta-blocker; or inability to tolerate these medications. 4. No changes in pharmacological treatment in the last 4 weeks. 5. Systolic blood pressure greater than or equal to 90 mmHg. 6. Informed consent to participate in the study. Exclusion Criteria: A hospitalization for heart failure less than one month ago. Chronic kidney disease: glomerular filtration rate estimated by the formula of CKD-EPI <30 ml / min / 1.73 m2. Hyponatremia: Sodium less than 130 mmol / l. Anemia: Hemoglobin less than 10 g / dl. Patients who will be taken to any type of intervention in the next 12 months in order to improve ventricular function, such as percutaneous coronary intervention or surgical revascularization Any valvulopathy of severe degree. Dementia Cancer Patients who have planned change of address in the next 12 months. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital de Cardiología, Centro Médico Nacional Siglo XXI | Ciudad de México |
Lead Sponsor | Collaborator |
---|---|
Instituto Mexicano del Seguro Social |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Estimated glomerular filtration rate | Glomerular filtration rate will be assessed with the CKD-EPI equation. | 20 weeks | |
Primary | Brain natriuretic peptide | Brain natriuretic peptide (NT-proBNP) will be compared at the end of the intervention. | 20 weeks | |
Secondary | Improvement in Quality of life | Quality of life will be compared with the Minnesota Living with Heart Failure Questionnaire. This is a self-applied questionnaire that contains 21 items, a total score and two dimensions: physical and emotional. The response options range from 0, which indicates unaffected quality of life, to 5, which indicates the maximum impact on the quality of life. The range of values of the questionnaire in general is 0-105; the physical dimension is 0-40; The emotional dimension is 0-25. In this study we will compare the overall result and the two dimensions. | 20 weeks | |
Secondary | Measured glomerular filtration rate | Measured glomerular filtration rate will be assessed with 24-hour creatinine clearance. | 20 weeks | |
Secondary | Renin plasmatic activity | Renin plasmatic activity will be assessed with ELISA. | 20 weeks | |
Secondary | Aldosterone | Aldosterone will be assessed with ELISA. | 20 weeks | |
Secondary | Composite clinical outcome | All-cause mortality or cardiovascular hospitalizations | 20 weeks | |
Secondary | NYHA functional class | The range of the NYHA functional class is I to IV, where I is the patient with the best functional class and IV is a patient with the worst functional class. | 20 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT03227393 -
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
|
N/A | |
Recruiting |
NCT04528004 -
Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
|
Early Phase 1 | |
Recruiting |
NCT04703842 -
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
|
Phase 1/Phase 2 | |
Recruiting |
NCT04522609 -
Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant
|
N/A | |
Completed |
NCT05475028 -
Network Medicine Approaches to Classify Heart Failure With PReserved Ejection Fraction by Signatures of DNA Methylation and Point-of-carE Risk calculaTors (PRESMET)
|
||
Not yet recruiting |
NCT05988749 -
Digital Remote Home Monitoring for Heart Failure
|
N/A | |
Not yet recruiting |
NCT06240403 -
Digoxin and Senolysis in Heart Failure and Diabetes Mellitus
|
Phase 2 | |
Recruiting |
NCT04950218 -
The Psoriasis Echo Study
|
||
Suspended |
NCT04701112 -
Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure
|
N/A | |
Completed |
NCT03305692 -
ECG Belt vs. Echocardiographic Optimization of CRT
|
N/A | |
Recruiting |
NCT05933083 -
MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation
|
N/A | |
Enrolling by invitation |
NCT03903107 -
The Fluoroless-CSP Trial Using Electroanatomic Mapping
|
N/A | |
Withdrawn |
NCT04872959 -
TRANSFORM Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT02920918 -
Treatment of Diabetes in Patients With Systolic Heart Failure
|
Phase 4 | |
Completed |
NCT02334891 -
Kyoto Congestive Heart Failure Study
|
||
Recruiting |
NCT03553303 -
Pharmacodynamic Effects of Sacubitril/Valsartan on Natriuretic Peptides, Angiotensin and Neprilysin
|
Phase 4 | |
Recruiting |
NCT04083690 -
Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients
|
N/A | |
Recruiting |
NCT03830957 -
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
|
N/A | |
Recruiting |
NCT06121323 -
Physiological Effects of Lactate in Individuals With Chronic Heart Failure
|
N/A | |
Recruiting |
NCT02960685 -
Telesonography for Visually Estimating Ejection Fraction
|
N/A |