Last reviewed · How we verify
Biomarker Guided Therapies in Stage A/B Heart Failure
Phase 2 trial testing Carvedilol in Hypertension in 58 participants. Completed in 15 December 2020.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 58 |
| Start date | 1 October 2014 |
| Primary completion | 15 December 2020 |
| Estimated completion | 15 December 2020 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 40 to 85, any sex, with Hypertension or Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in myocardial speckle tracked strain (global longitudinal strain) after 18 months (baseline vs. 18 months) of therapy with carvedilol or spironolactone or usual care. The myocardial global longitudinal strain was measured using echocardiography
| Group | Value | 95% CI |
|---|---|---|
| Carvedilol | -1.4 | ± 4.4 |
| Spironolactone | -1.74 | ± 3.25 |
| Usual Care | -1.14 | ± 4.13 |
Change in levels of NT-proBNP (measured in blood samples) between baseline and 18 months after therapy with carvedilol or spironolactone or usual care
| Group | Value | 95% CI |
|---|---|---|
| Carvedilol | 87.9 | ± 243.5 |
| Spironolactone | -16.5 | ± 39.3 |
| Usual Care | 3.65 | ± 91.03 |
Changes in arterial stiffness between baseline and 18 months after therapy with carvedilol, spironolactone or usual care. Arterial stiffness was measured by pulse wave velocity (Sphygmocor device)
| Group | Value | 95% CI |
|---|---|---|
| Carvedilol | -0.71 | ± 1.6 |
| Spironolactone | -0.77 | ± 5.7 |
| Usual Care | -0.59 | ± 3.4 |
Change in levels of troponin T (measured with a high sensitivity assay in blood samples) between baseline and 18 months after therapy with carvedilol or spironolactone or usual care
| Group | Value | 95% CI |
|---|---|---|
| Carvedilol | -0.2 | ± 5.2 |
| Spironolactone | 1.4 | ± 3.9 |
| Usual Care | 0.35 | ± 6.0 |
Time frame: The study had a follow up period of 18 months from randomization during which subjects were followed for adverse events. However, 4 subjects had longer follow up due to the coronavirus infection of 2019 (COVID 19) and inability to schedule follow ups (approximately 6 to 8 months additional follow up for these subjects). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Carvedilol | Spironolactone | Usual Care |
|---|---|---|---|---|
| Hospitalization for chest pain/ heart failure | Cardiac disorders | — | — | — |
| Hospitalization for falls, accidents | Musculoskeletal and connective tissue disorders | — | — | — |
| Hospitalization for planned surgery | General disorders | — | — | — |
| Hospitalization for infection | Infections and infestations | — | — | — |
| Hypotension, ER visit | Cardiac disorders | — | — | — |
| Hospitalization for shortness of breath | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Reaction | System | Carvedilol | Spironolactone | Usual Care |
|---|---|---|---|---|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Breast tenderness | Endocrine disorders | — | — | — |
| Renal dysfunction | Renal and urinary disorders | — | — | — |
| abdominal discomfort | Gastrointestinal disorders | — | — | — |
| Dizziness/ Drowsiness/ Disequilibrium | Cardiac disorders | — | — | — |
| chest pain | Cardiac disorders | — | — | — |
| Fatigue | Musculoskeletal and connective tissue disorders | — | — | — |
| Falls | Nervous system disorders | — | — | — |
| Weight loss | Endocrine disorders | — | — | — |
| Atrial arrhythmia | Cardiac disorders | — | — | — |
Most-reported serious reactions: Hospitalization for chest pain/ heart failure, Hospitalization for falls, accidents, Hospitalization for planned surgery, Hospitalization for infection, Hypotension, ER visit, Hospitalization for shortness of breath.
Data from ClinicalTrials.gov NCT02230891 adverse events section.
Despite advances in cardiovascular care, the occurrence of heart failure (HF) is steadily increasing. The increase in HF rates poses enormous challenges, as once an individual becomes symptomatic or requires hospitalization with HF, the prognosis remains poor. Therefore, prevention of HF is essential. HF prevention is a critical issue as HF risk factors that include common medical conditions such as hypertension and diabetes are also increasing. However, not everyone with these risk factors develops HF. Using novel blood tests, the investigators propose to identify and treat subjects at higher HF risk to see if the investigators can stabilize or improve ultrasound measures known to be associated with HF risk. This study will enroll only Veterans.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02230891.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing