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Outcomes With sGC Therapy in Patients With HFpEF: A Meta-Analysis of Prior Trials
Ravi A Thakker1, Ayman Elbadawi2, Aiham Albaeni3
1Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX.
Insights
Soluble guanylate cyclase (sGC) agents did not improve heart failure with preserved ejection fraction (HFpEF) outcomes in trials. Analysis showed no significant difference in 6-minute walk test or quality of life scores.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Soluble guanylate cyclase (sGC) agents show potential in heart failure treatment.
- However, their efficacy in heart failure with preserved ejection fraction (HFpEF) remains uncertain.
- Recent trials like CAPACITY HFpEF and VITALITY-HFpEF did not demonstrate benefits.
Purpose of the Study:
- To analyze existing data on sGC agents in HFpEF patients.
- To evaluate the impact on 6-minute walk test (6MWT) distance and Kansas City Cardiomyopathy Questionnaire (KCCQ) physical limitation score (PLS).
- To assess the safety profile of sGC agents in HFpEF.
Main Methods:
- Systematic review and meta-analysis of data from CAPACITY HFpEF and VITALITY-HFpEF trials.
- Inclusion of data from SOCRATES-PRESERVED and DILATE-1 trials for safety analysis.
- Analysis of 6MWT and KCCQ PLS outcomes, alongside serious adverse events.
Main Results:
- Analysis included 620 patients for 6MWT and 583 for KCCQ PLS.
- No significant difference was observed in 6MWT distance (P=0.97) between sGC and placebo groups.
- No significant difference was found in KCCQ PLS (P=0.83) or serious adverse events (P=0.67).
Conclusions:
- Soluble guanylate cyclase agents do not significantly improve 6MWT or KCCQ PLS in HFpEF patients.
- The safety profile of sGC agents in this population appears comparable to placebo.
- Further research may be needed to identify specific patient subgroups who could benefit from sGC therapy.
Abstract:
Soluble guanylate cyclase (sGC) agents have been shown to have possible beneficial effects in heart failure treatment. Unfortunately, the role of sGC in HFpEF has not been shown to be efficacious based on recent trials. The CAPACITY HFpEF and VITALITY-HFpEF trials independently showed that sGC does not improve 6-minute walk test (6MWT) distance or the Kansas City Cardiomyopathy Questionnaire (KCCQ) physical limitation score (PLS). The objective of this study was to analyze current data on the 6MWT and KCCQ PLS score from trials that included patients with HFpEF treated with sGC. Using MEDLINE and Cochrane databases, meta-analysis and systematic review was performed looking at data in the CAPACITY HFpEF and VITALITY-HFpEF trials. For safety analysis we evaluated serious adverse events between the CAPACITY HFpEF, VITALITY-HFpEF, SOCRATES-PRESERVED, and DILATE-1trials. A total of 2 trials were analyzed to assess 6MWT and KCCQ score. The total number of combined patients from both trials assessing 6MWT distance in sGC vs placebo therapy were 620 with 309 in the treatment group and 311 in the placebo group. The total number of combined patients from both trials assessing KCCQ score outcomes were 583 with 280 in the treatment group and 303 in the placebo group. A total of 4 trials were evaluated for safety analysis with a total of 987 patients with 529 in the treatment group and 458 in the placebo group. The analysis did not demonstrate significant difference in 6MWT (P = 0.97), KCCQ PLS (P = 0.83), or serious adverse events (P = 0.67).
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