Given potential benefits in the Americas subgroup in TOPCAT, mineralocorticoid receptor antagonists can be considered in appropriately selected patients with HFpEF to reduce risk of heart failure hospitalization. Significant regional variation may impact the success of global HFpEF trials. Subsequent analyses of TOPCAT have revealed marked regional heterogeneity in patient profiles, event rates, drug adherence, and treatment effects.
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We identify key lessons from the TOPCAT experience that can be applied to future HFpEF trials.
TOPCAT TRIAL TRIAL
We have not analysed the data ourselves.Spironolactone did not demonstrate benefit with respect to the primary composite endpoint in the global TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial in patients with chronic heart failure with preserved ejection fraction (HFpEF). The figures we quote above were provided by the trial team who did the research. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. We have based this summary on information from the research team. They feel it would be possible to run a larger trial to look at nurse led follow up in more detail. And that it may cost less and improve quality of life. The research team concluded that nurse led follow up was acceptable to patients. But again it wasn’t a big enough difference to be sure that it was because of the type of follow up. They found that overall the cost of nurse led follow up was slightly less. The research team also looked at how much the different types of follow up cost. But the difference wasn’t big enough to say for sure that it was because of the type of follow up. The people who had nurse led follow up had a slightly larger increase in quality of life.
![topcat trial topcat trial](https://ars.els-cdn.com/content/image/1-s2.0-S2213177918304645-fx1.jpg)
The research team analysed the quality of life questionnaires and found that there wasn’t much difference between the two groups. No one had treatment for vulval cancer at the hospitals taking part during the time the trial was open for people to join (the recruitment period). And about half had also had either radiotherapy or chemotherapy. They had already had an operation to remove the cancer.
![topcat trial topcat trial](https://europepmc.org/articles/PMC6334030/bin/clinmed-18-2s-s24fig3.jpg)
When they reached a year after treatment, they continued to have the usual follow up for their type of cancer.
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They also filled out some quality of life questionnaires before they started the follow up programme and just before each appointment or phone call.