Clinical Trials List
2018-08-24 - 2021-01-29
Phase II
Terminated4
ICD-10I50
Heart failure
A randomized parallel-group, placebo-controlled, double-blind, multi-center trial to eValuate the effIcacy and safeTy of the orAL sGC stImulator vericiguaT to improve physical functioning in activities of daily living in patients with heart failure and preserved ejection fraction (VITALITY-HFpEF)
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tse-Min Lu Division of Cardiovascular Diseases
- Shih-Hsien Sung Division of Cardiovascular Diseases
- Kang-Ling Wang Division of Cardiovascular Diseases
- Hao-min Cheng Division of Cardiovascular Diseases
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃少嵩 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
8 Terminated
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Tablets
Tablets
Dosage
5
10
Endpoints
將在基期、第 2、6、12、和24 週評估 KCCQ PLS
Inclution Criteria
2. Aged 45 years and older
3. Previous history of chronic HF
4. HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or IV diuretic treatment for HF without hospitalization.
Exclusion Criteria
o Any IV treatment including IV diuretics or IV fluids within 24h prior to randomization
o SBP ≥160 mmHg
o SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
o Resting HR <50 or ≥100 bpm
2. Use of IV inotropes at any time between qualifying HF event and randomization
3. Previous diagnosis of reduced EF (EF <40%)
The Estimated Number of Participants
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Taiwan
35 participants
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Global
735 participants
