Endocalyx for Heart Failure
The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx Pro reduces sodium and water excess in patients with chronic heart failure. The main questions it aims to answer are: 1. To assess whether the food supplement Endocalyx reduces sodium and water excess
| Condition(s) | Chronic Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx Pro reduces sodium and water excess in patients with chronic heart failure. The main questions it aims to answer are: 1. To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure. 2. To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients. 3. To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life. 4. To confirm the previously demonstrated safety of Endocalyx in subjects with chronic heart failure. Participants will be randomized to Endocalyx Pro or Placebo daily for 8 weeks, |
| Who can participate | Inclusion Criteria: 1. Documented or suspected heart failure with reduced ejection fraction (HFrEF and HFmrEF according to ESC guidelines). 2. Signs of congestion, defined as: a. Elevated NT-proBNP levels: i. \>450 pg/ml in subjects aged \<55 years. ii. \>900 pg/ml in subjects aged 55-75 years. iii. \>1800 pg/ml in subjects aged \>75 years. AND b. Use of diuretics, OR c. Presence of peripheral edema, OR d. Complaints of orthopnea or paroxysmal nocturnal dyspnea, OR e. A chest X-rays with sings of volume overload, OR f. Hypertension, as defined by an office blood pressure \>140/90 mmHg. 3. Stable diuretic and antihypertensive treatment for the previous 3 weeks. 4. Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Lead sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Locations | Amsterdam, North Holland, Netherlands |
| Start date | 2023-04-21 |
| NCT ID | NCT05966415 |
| Official listing | https://clinicaltrials.gov/study/NCT05966415 |